NO DRUGS, NO SURGERY, NO SIDE-EFFECTS:
82% of sufferers had a 77% reduction within 8 weeks and continue to improve
Mishawaka, IN, July 10, 2001
The FDA has granted marketing allowance for the NTI Tension Suppression System (NTI-tss) neuromuscular suppression device indicated for the prevention of medically diagnosed migraine pain and associated tension-type headaches.
In a multicenter trial, the NTI-tss device was shown to considerably reduce or eliminate migraine and associated tension headache pain. It is considered breakthrough technology in that there is, when used as directed, no risk of side-effects associated with it compared to many current pharmaceutical migraine preventatives.
Patients who experience migraine headaches typically contract their temporalis muscles (which cover the entire sides of the skull and are the most powerful muscles of the body) during sleep on average 14 times more intensely than those who do not experience them, and have been found to exhibit 'pericranial tenderness' (muscle tenderness of the scalp), setting the stage for migraine and tension headache attacks.
Typical sufferers awake nearly every morning with varying degrees of headache pain but have come to accept it as normal and unremarkable. The NTI-tss device is a small, removable, prefabricated matrix which a dentist custom fits to a patients front teeth to be worn while sleeping. With the NTT-tss device in place, the intense activity of the temporal muscles (which close and clench the jaw) is suppressed to less than 1/3 of maximum by preventing any contacting of the back molar or canine teeth. By reducing this neuromuscular activity, migraine headache pain attacks are reduced or prevented all together, as well as the associated tension-type headaches.
23 million people older than 12 years of age suffer severe migraine headaches. The social and economic impact of migraine is staggering, with estimates approaching $17.2 billion per year lost in productivity (The 1992 American Migraine Study, Journal of the American Medical Association)
The pivotal NTI-tss trial compared the effect of the NTI-tss device to a control device on medically diagnosed migraine sufferers. Each subject had at least 2 migraines per month and had a physicians prescription for Imitrex (sumatriptan, GlaxoSmithKline) as a rescue medication.
After just eight weeks of using the NTI-tss:
- There were no side-effects and no new pain;
- 82% of NTI-tss users had a 77% average reduction in migraine events;
- Imitrex use was reduced by almost 50%
- Nausea episodes were reduced by 78%
- Light-sensitive episodes were reduced by 66%
- Sound-sensitive episodes were reduced by 68%
Dentists can fabricate and deliver the NTI-tss device in a single visit. Many dentists across the country are already highly experienced with NTI-tss use after having been providing it over the past two years for its earlier indications for the prevention of TMJ syndrome, clenching and grinding.
NTI-TSS, Inc., the manufacturer of the NTI-tss device, is located in Mishawaka, Indiana, and has a website, http://www.nti-tss.com.
The CEO and developer of the NTI-tss patents and protocol is James P. Boyd, DDS, an ex-migraine sufferer who had developed the concept for his own relief. http://www.DrJimBoyd.com
Bob Weber, Regulatory Affairs, NTI-TSS, Inc. (219) 258-5963